Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00824161|
Recruitment Status : Terminated
First Posted : January 16, 2009
Results First Posted : August 17, 2011
Last Update Posted : April 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Advanced Colorectal Cancer||Drug: TAS-109||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||December 2010|
14-day continuous central intravenous infusion at a dose of 2.0 mg/m2/day followed by a 7-day rest period.
Number of cycles: until unacceptable toxicity or disease progression requires discontinuation.
- Percentage of Progression Free Survival [ Time Frame: From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months. ]The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.
- Antitumor Activity [ Time Frame: From the date of initial treatment until the date of the first objective documentation of PD or death from any cause. ]Per RECIST Criteria and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response rate was defined as percentage of patients of CR plus PR in ITT population.
- Overall Survival [ Time Frame: From the initial treatment until 12 months after enrollment of the last patient. ]Overall survival is defined as the period from the date of first dose of TAS-109 to death date.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824161
|United States, New York|
|NYU Cancer Institute|
|East 34th Street, New York, New York, United States, NY 10016|
|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center|
|Holcombe Boulevard, Houston, Texas, United States, TX 77030|
|The Center for Cancer and Blood Disorders|
|West Magnolia Avenue, Fort Worth, Texas, United States, TX 76104|
|Principal Investigator:||Henry Xiong, M.D., Ph.D.||The Center for Cancer and Blood Disorders|